COVID-19 Clinical Trial
Official title:
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance. Cohort 1: Around 4500 participants will be assigned by chance to one of the following: - Group A:Influenza and COVID-19 combination A vaccine, given at the same time in the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm. - Group B: COVID-19 vaccine, given at the same time to the right arm and licensed influenza vaccine in the left arm. Cohort 2: Around 4500 participants will be assigned by chance to one of the following: - Group C: Influenza and COVID-19 combination B vaccine, given at the same time in the right arm and placebo in the left arm. - Group D: COVID-19 vaccine, given at the same time in the right arm and licenced influenza vaccine in the left arm. All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.
| Status | Recruiting |
| Enrollment | 7500 |
| Est. completion date | December 5, 2024 |
| Est. primary completion date | December 5, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility | Inclusion Criteria: - Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. - Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: - Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. - Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration. Please refer to the study contact for further eligibility details |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico |
| United States | North Alabama Research Center | Athens | Alabama |
| United States | Synexus Clinical Research US, Inc. | Atlanta | Georgia |
| United States | Benchmark Research | Austin | Texas |
| United States | Optimal Research | Austin | Texas |
| United States | Orion Clinical Research | Austin | Texas |
| United States | Orion Clinical Research | Austin | Texas |
| United States | Tekton Research, LLC. | Austin | Texas |
| United States | Pharmaron | Baltimore | Maryland |
| United States | Velocity Clinical Research, Banning | Banning | California |
| United States | Accel Research Sites Network - Birmingham Clinical Research Unit | Birmingham | Alabama |
| United States | Internal Medicine and Pediatric Associates of Bristol | Bristol | Tennessee |
| United States | Headlands Horizons LLC | Brownsville | Texas |
| United States | Capital Area Research, LLC | Camp Hill | Pennsylvania |
| United States | Hope Clinical Research, Inc. | Canoga Park | California |
| United States | ACRC TRIALS / Family Medicine Associates of Texas | Carrollton | Texas |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Clinical Research Professionals | Chesterfield | Missouri |
| United States | Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois |
| United States | Synexus Clinical Research US, Inc. | Chicago | Illinois |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Synexus Clinical Research US, Inc. | Cincinnati | Ohio |
| United States | Velocity Clinical Research, Mt. Auburn | Cincinnati | Ohio |
| United States | Tampa Bay Medical Research | Clearwater | Florida |
| United States | Centricity Research Columbus Georgia Multispecialty | Columbus | Georgia |
| United States | Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio |
| United States | DFW Clinical Research | Dallas | Texas |
| United States | North Texas Infectious Diseases Consultants, P.A | Dallas | Texas |
| United States | Synexus Clinical Research US, Inc. | Dallas | Texas |
| United States | Universal Axon Clinical Research, LLC | Doral | Florida |
| United States | West Coast Research | Dublin | California |
| United States | Duke Vaccine and Trials Unit | Durham | North Carolina |
| United States | Michigan Center of Medical Research (MICHMER) | Farmington Hills | Michigan |
| United States | Proactive Clinical Research,LLC | Fort Lauderdale | Florida |
| United States | Benchmark Research | Fort Worth | Texas |
| United States | Texas Health Family Care | Fort Worth | Texas |
| United States | Ascada Health PC dba Ascada Research | Fullerton | California |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | Velocity Clinical Research, Grand Island | Grand Island | Nebraska |
| United States | Finlay Medical Research | Greenacres City | Florida |
| United States | Great Lakes Clinical Trials - Gurnee | Gurnee | Illinois |
| United States | Best Quality Research,Inc. | Hialeah | Florida |
| United States | Indago Research & Health Center, Inc | Hialeah | Florida |
| United States | Accellacare - Hickory | Hickory | North Carolina |
| United States | Research Centers of America ( Hollywood ) | Hollywood | Florida |
| United States | East-West Medical Research Institute | Honolulu | Hawaii |
| United States | DM Clinical Research - Bellaire | Houston | Texas |
| United States | Santa Clara Family Clinic | Houston | Texas |
| United States | Marvel Clinical Research | Huntington Beach | California |
| United States | Medical Affiliated Research Center | Huntsville | Alabama |
| United States | Clinical Research Prime | Idaho Falls | Idaho |
| United States | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida |
| United States | Alliance for Multispecialty Research, LLC | Kansas City | Missouri |
| United States | Accellacare US Inc., d/b/a Accellacare of Knoxville | Knoxville | Tennessee |
| United States | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee |
| United States | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee |
| United States | New Phase Research and Development | Knoxville | Tennessee |
| United States | Velocity Clinical Research, San Diego | La Mesa | California |
| United States | Orange County Research Center | Lake Forest | California |
| United States | Excel Clinical Research, LLC | Las Vegas | Nevada |
| United States | Las Vegas Clinical Trials | Las Vegas | Nevada |
| United States | Wr-Crcn, Llc | Las Vegas | Nevada |
| United States | Tekton Research, LLC. | Lawrenceville | Georgia |
| United States | Alliance for Multispecialty Research, LLC | Layton | Utah |
| United States | Main Street Physician's Care | Little River | South Carolina |
| United States | Baptist Health Center for Clinical Research | Little Rock | Arkansas |
| United States | Ark Clinical Research | Long Beach | California |
| United States | Collaborative Neuroscience Research, LLC | Los Alamitos | California |
| United States | Kaiser Permanente | Los Angeles | California |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Velocity Clinical Research, Westlake | Los Angeles | California |
| United States | Velocity Clinical Research, Medford | Medford | Oregon |
| United States | Optimal Research | Melbourne | Florida |
| United States | Clinical Neuroscience Solutions Inc. | Memphis | Tennessee |
| United States | Solaris Clinical Research | Meridian | Idaho |
| United States | Velocity Clinical Research, Boise | Meridian | Idaho |
| United States | SMS Clinical Research | Mesquite | Texas |
| United States | SMS Clinical Research | Mesquite | Texas |
| United States | Angels Clinical Research Institute | Miami | Florida |
| United States | Clinical Site Partners LLC, dba Flourish Research | Miami | Florida |
| United States | Entrust Clinical Research | Miami | Florida |
| United States | Gerardo Polanco, MD | Miami | Florida |
| United States | Miami Clinical Research | Miami | Florida |
| United States | Miami Dade Medical Research Institute, LLC | Miami | Florida |
| United States | Research Institute of South Florida | Miami | Florida |
| United States | Palm Springs Community Health Center | Miami Lakes | Florida |
| United States | Panax Clinical Research | Miami Lakes | Florida |
| United States | Clinical Research Consulting | Milford | Connecticut |
| United States | Alliance for Multispecialty Research, LLC | Mobile | Alabama |
| United States | Monroe Biomedical Research | Monroe | North Carolina |
| United States | Koch Family Medicine | Morton | Illinois |
| United States | Trial Management Associates | Myrtle Beach | South Carolina |
| United States | NYU Langone Health | New York | New York |
| United States | Health Research of Hampton Roads, Inc. | Newport News | Virginia |
| United States | Alliance for Multispecialty Research, LLC | Norfolk | Virginia |
| United States | Lynn Institute of Norman | Norman | Oklahoma |
| United States | Coastal Carolina Research Center | North Charleston | South Carolina |
| United States | Velocity Clinical Research, North Hollywood | North Hollywood | California |
| United States | Las Vegas Clinical Trials | North Las Vegas | Nevada |
| United States | Affinity Health | Oak Brook | Illinois |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Quality Clinical Research | Omaha | Nebraska |
| United States | Velocity Clinical Research, Omaha | Omaha | Nebraska |
| United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
| United States | Innovation Medical Research Center | Palmetto Bay | Florida |
| United States | McGill Family Practice | Papillion | Nebraska |
| United States | Pasadena Clinical Trials - South Arroyo Parkway | Pasadena | California |
| United States | DBC Research USA | Pembroke Pines | Florida |
| United States | DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania |
| United States | Foothills Research Center/ CCT Research | Phoenix | Arizona |
| United States | HOPE Research Institute | Phoenix | Arizona |
| United States | The Pain Center of Arizona | Phoenix | Arizona |
| United States | ACRC Trials (Administrative Location) | Plano | Texas |
| United States | ACRC Trials (Administrative Location) | Plano | Texas |
| United States | ACRC TRIALS / North Texas Family Medicine | Plano | Texas |
| United States | AIM Trials, LLC | Plano | Texas |
| United States | United Medical Research | Port Orange | Florida |
| United States | ActivMed Practices & Research, LLC. | Portsmouth | New Hampshire |
| United States | M3 Wake Research, Inc. | Raleigh | North Carolina |
| United States | Clinical Research Partners, LLC | Richmond | Virginia |
| United States | Artemis Institute for Clinical Research | Riverside | California |
| United States | Rochester Clinical Research, LLC | Rochester | New York |
| United States | Advanced Primary and Geriatric Care - CCT Research | Rockville | Maryland |
| United States | Accellacare - Rocky Mount | Rocky Mount | North Carolina |
| United States | Benchmark Research | Sacramento | California |
| United States | Saint Louis University Center for Vaccine Development | Saint Louis | Missouri |
| United States | Sundance Clinical Research | Saint Louis | Missouri |
| United States | Accellacare - Salisbury | Salisbury | North Carolina |
| United States | J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah |
| United States | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, LLC | San Antonio | Texas |
| United States | IMA Clinical Research San Antonio | San Antonio | Texas |
| United States | Acclaim Clinical Research | San Diego | California |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Optimal Research San Diego | San Diego | California |
| United States | AGILE Clinical Research Trials, LLC | Sandy Springs | Georgia |
| United States | Velocity Clinical Research, Savannah | Savannah | Georgia |
| United States | Scottsdale Clinical Trials | Scottsdale | Arizona |
| United States | Scottsdale Clinical Trials | Scottsdale | Arizona |
| United States | Jadestone Clinical Research | Silver Spring | Maryland |
| United States | Velocity Clinical Research, Sioux City | Sioux City | Iowa |
| United States | J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah |
| United States | Headlands Research - Detroit | Southfield | Michigan |
| United States | DelRicht Research | Springfield | Missouri |
| United States | DelRicht Research - Springfield | Springfield | Missouri |
| United States | Revival Research Institute | Sterling Heights | Michigan |
| United States | Clinical Research Atlanta | Stockbridge | Georgia |
| United States | Sugar Lakes Family Practice, PA | Sugar Land | Texas |
| United States | Angels Clinical Research Institute | Tampa | Florida |
| United States | Alliance for Multispecialty Research, LLC | Tempe | Arizona |
| United States | DM Clinical Research | Tomball | Texas |
| United States | Northwest Houston Heart Center | Tomball | Texas |
| United States | Oakland Medical Research | Troy | Michigan |
| United States | Orange County Research Center | Tustin | California |
| United States | Bayview Research Group, LLC | Valley Village | California |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| United States | IMA Clinical Research Warren | Warren | New Jersey |
| United States | Velocity Clinical Research, Salt Lake City | West Jordan | Utah |
| United States | Alliance for Multispecialty Research, LLC | Wichita | Kansas |
| United States | Accellacare - Wilmington | Wilmington | North Carolina |
| United States | Trial Management Associates - Wilmington - Floral Parkway | Wilmington | North Carolina |
| United States | Trial Management Associates, LLC | Wilmington | North Carolina |
| United States | Accellacare - Winston-Salem | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| BioNTech SE | Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants reporting prompted local reactions within 7 days following investigational product administration in the right deltoid | Describe prompted local reactions following investigational product administration | Day 7 | |
| Primary | Percentage of participants reporting prompted systemic events within 7 days following investigational product administration | Describe prompted systemic events following investigational product administration | Day 7 | |
| Primary | Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration | Describe AEs occurring through 4 weeks following administration of investigational product | 4 weeks after vaccination | |
| Primary | Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration | Describe SAEs through 6 months following administration of investigational product | 6 months after vaccination | |
| Primary | GMR of HAI titers in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by licensed influenza vaccine and COVID-19 concomitant administration group | 4 weeks after vaccination | |
| Primary | The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by Licensed influenza vaccine and COVID-19 concomitant administration group. | 4 weeks after vaccination | |
| Primary | GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | |
| Primary | The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to subjects having received licensed influenza vaccine and COVID-19 concomitant administration group | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | |
| Primary | GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19 | 4 weeks after vaccination | |
| Primary | The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19 | 4 weeks after vaccination | |
| Primary | GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | |
| Primary | The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19 | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination |
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